Vedrop

tocofersolan

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Vedrop?

Vedrop is an oral solution that contains the active substance tocofersolan.

What is Vedrop used for?

Vedrop is used to treat or prevent vitamin-E deficiency (low vitamin-E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Congenital or hereditary chronic cholestasis is an inherited disease causing problems with the flow of bile from the liver to the gut. Bile is a fluid produced in the liver that helps to absorb fats from the gut.

The medicine can only be obtained with a prescription.

How is Vedrop used?

Treatment with Vedrop should be started and supervised by a doctor who has experience in treating patients with congenital or hereditary chronic cholestasis.

Vedrop is given by mouth, with or without water. The recommended daily dose is 0.34 ml per kilogram body weight. This dose should be adjusted depending on the amount of vitamin E in the child’s blood. This should be checked regularly.

How does Vedrop work?

Vitamin E is a natural substance that cannot be made by the body and is therefore needed in the diet. It has a number of actions in the body, including protecting the nervous system from damage. Because vitamin E is soluble in fats and not water, it can only be absorbed from the gut into the body alongside fat particles. Patients with cholestasis may have low vitamin-E levels because they have problems absorbing fats from the gut.

The active substance in Vedrop, tocofersolan, is vitamin E that has been made water soluble by attaching it to a chemical called polyethylene glycol. Tocofersolan can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin-E levels in the blood and help to prevent neurological deterioration (problems in the nervous system) due to vitamin-E deficiency.

How has Vedrop been studied?

The effects of Vedrop were first tested in experimental models before being studied in humans. To support the use of Vedrop, the company presented information from the scientific literature, including the results of three studies in a total of 92 children and adolescents with chronic cholestasis who were given tocofersolan for about two years. The patients all had vitamin-E deficiency that was not responding to other vitamin-E treatments given by mouth. The main measures of effectiveness were the level of vitamin E in the blood and the number of children whose neurological symptoms improved or stayed the same.

The company also presented information on the use of Vedrop in patients with cystic fibrosis, but withdrew its application for this disease during the evaluation of the medicine.

What benefit has Vedrop shown during the studies?

The studies showed that Vedrop could correct vitamin-E levels in patients with chronic cholestasis and that it might improve or prevent neurological symptoms, especially in patients aged below three years.

What is the risk associated with Vedrop?

The most common side effect with Vedrop (seen in between 1 and 10 patients in 100) is diarrhoea. For the full list of all side effects reported with Vedrop, see the package leaflet. Vedrop should not be used in people who may be hypersensitive (allergic) to tocofersolan or any of the other ingredients. It must not be used in premature babies.

Why has Vedrop been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Vedrop’s benefits are greater than its risks for vitamin-E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region. The Committee recommended that Vedrop be given marketing authorisation.

Vedrop has been authorised under ‘exceptional circumstances’. This means that because the disease is rare, it has not been possible to obtain complete information about Vedrop. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Vedrop?

The company that makes Vedrop will work with other companies to assess the possible effects of propylparaben (a preservative used in Vedrop) on the reproductive organs. The company will also set up a registry of patients with congenital or hereditary chronic cholestasis.

Other information about Vedrop

The European Commission granted a marketing authorisation valid throughout the European Union for Vedrop to Orphan Europe S.A.R.L. on 24 July 2009.

Name Language First published Last updated
Vedrop : EPAR - Summary for the public BG = bălgarski 06/08/2009  
Vedrop : EPAR - Summary for the public ES = español 06/08/2009  
Vedrop : EPAR - Summary for the public CS = čeština 06/08/2009  
Vedrop : EPAR - Summary for the public DA = dansk 06/08/2009  
Vedrop : EPAR - Summary for the public DE = Deutsch 06/08/2009  
Vedrop : EPAR - Summary for the public ET = eesti keel 06/08/2009  
Vedrop : EPAR - Summary for the public EL = elliniká 06/08/2009  
Vedrop : EPAR - Summary for the public EN = English 06/08/2009  
Vedrop : EPAR - Summary for the public FR = français 06/08/2009  
Vedrop : EPAR - Summary for the public IT = italiano 06/08/2009  
Vedrop : EPAR - Summary for the public LV = latviešu valoda 06/08/2009  
Vedrop : EPAR - Summary for the public LT = lietuvių kalba 06/08/2009  
Vedrop : EPAR - Summary for the public HU = magyar 06/08/2009  
Vedrop : EPAR - Summary for the public MT = Malti 06/08/2009  
Vedrop : EPAR - Summary for the public NL = Nederlands 06/08/2009  
Vedrop : EPAR - Summary for the public PL = polski 06/08/2009  
Vedrop : EPAR - Summary for the public PT = português 06/08/2009  
Vedrop : EPAR - Summary for the public RO = română 06/08/2009  
Vedrop : EPAR - Summary for the public SK = slovenčina 06/08/2009  
Vedrop : EPAR - Summary for the public SL = slovenščina 06/08/2009  
Vedrop : EPAR - Summary for the public FI = suomi 06/08/2009  
Vedrop : EPAR - Summary for the public SV = svenska 06/08/2009  

This EPAR was last updated on 29/01/2015 .

Authorisation details

Product details

Product details for Vedrop
NameVedrop
Agency product numberEMEA/H/C/000920
Active substance

tocofersolan

International non-proprietary name (INN) or common name

tocofersolan

Therapeutic area Vitamin E DeficiencyCholestasis
Anatomical therapeutic chemical (ATC) code A11HA08
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Vedrop
Marketing-authorisation holder

Orphan Europe S.A.R.L.

Revision8
Date of issue of marketing authorisation valid throughout the European Union24/07/2009

Contact address:

Orphan Europe S.A.R.L.
Immeuble "Le Wilson"
FR-92800 Puteaux
France

Product information

Product information

22/01/2015  Vedrop -EMEA/H/C/000920 -S/0012

Name Language First published Last updated
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015
Vedrop : EPAR - Product Information SV = svenska 06/08/2009 29/01/2015

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  
Vedrop : EPAR - All Authorised presentations SV = svenska 06/08/2009  

Pharmacotherapeutic group

Vitamins

Therapeutic indication

Vedrop is indicated in vitamin-E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Vedrop : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 19/04/2011 29/01/2015

Initial marketing-authorisation documents

Name Language First published Last updated
Vedrop : EPAR - Public assessment report SV = svenska 06/08/2009  
Committee for medicinal products for human use, summary of positive opinion for Vedrop SV = svenska 29/05/2009  

Authorised

This medicine is approved for use in the European Union